Full-Time
Manager – Quality Control
Confirmed live in the last 24 hours
Automated cell therapy manufacturing platform
Data & Analytics
Hardware
Mid, Senior
San Bruno, CA, USA
Requirements
- Bachelor's degree in a science discipline required, or comparable experience.
- Master's degree in a scientific discipline is preferred
- 7+ years experience in a cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment
- At least 2 years in a managerial role
- Prior experience related to method development/validation
- Strong background in cell biology, immunology, and molecular biology
- Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211
- Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, analytical testing, and auditing
- Identifying, authoring, and supporting OOS, DRs, and CAPAs
- Equipment IQ/OQ/PQ experience
- Proficient in MS Office products including, Word, Excel, Outlook, and Power Point
- Excellent interpersonal, verbal, written communication and organization skills
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
- Must be able to commute to South San Francisco
Responsibilities
- Schedule/Manage routine and non-routine analysis of in-process, raw materials, finished goods, or stability samples
- Ensure the quality control lab is held to GxP standards and safety standards
- Create, review and approve Certificate of Analysis
- Conduct investigation regarding out of specifications (OOS) results and address and manage deviations related to analytical procedures
- Review and approve data to ensure accuracy and regulatory compliance
- Collaborate with QC Microbiology management in establishing specifications and justification of specifications
- Create, review and approve new and revision of analytical test methods
- Create, review and approve method validation protocols/reports and other documentation such as analytical reports
- Create, review and approve stability protocols and reports
- Create, review and approve quality control operation procedures
- Manage the validation of analytical methods used in QC as well as the transfer and validation of methods to contract testing laboratories
- Manage training of other analysts to perform laboratory procedures and assays
- Participate in internal assessments and audits as required
- Manage stability program
- Serve as Quality Control representative during cross-functional/project meetings
- Serve as subject matter expert between Quality Control and other departments, vendors, or contractors
- Behave as a working backup QC analyst for testing activities as needed
- Support Quality Systems such as Change Control, Deviation, CAPA, Audits, Quality Metrics
- Manage and grow a phase appropriate team of Quality Control personnel
- Establish user requirements for purchase of new Cellares GMP lab equipment
- Manage equipment validation, calibration, maintenance, and troubleshooting
- Assemble and report contract laboratory testing data
- Assist in the preparation of dossiers and data packages in support of Cellares' products for regulatory agencies
- Other duties as assigned
Cellares specializes in advanced cell therapy manufacturing with its proprietary Cell Shuttle platform. This platform exemplifies industry leadership by integrating state-of-the-art automation and software solutions, significantly reducing process failure rates and costs. Working at this company provides the unique opportunity to contribute to life-saving innovations while being part of a culturally rich environment that collaborates with top-tier academic and industry partners worldwide.
Company Stage
Series C
Total Funding
$373M
Headquarters
South San Francisco, California
Founded
2019
Growth & Insights
Headcount